Skin Cancer Prevention Strategies for Skin Cancer

(RISE-UP Trial)

Overseen By Ben Weitzman

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Utah

Disqualifiers: Non-English speakers, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

528 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study is a Multiphase Optimization Strategy (MOST) that uses factorial experiments to evaluate individual and combined effects of intervention components to improve intervention efficiency. The study team anticipates enrolling a total of 528 undergraduate students (\>18 years) into the trial to identify intervention approaches that eliminate sunburn, and secondarily to motivate sun protection and discourage tanning. The study team will test personalized risk components: 1) UV Photo, 2) Action Plan, and 3) MC1R Testing. A full factorial experiment will be conducted to test which of the proposed components or their combinations eliminate sunburn over one year. The study team will also examine effects of the intervention on secondary outcomes. Study assessments will be completed at 4 time points: baseline, 1-month post-intervention, 4-months post-intervention, and 15-months post-intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for skin cancer prevention strategies?

Research shows that educational interventions, such as personalized UV damage photographs, can significantly improve sun protection behaviors and reduce sunburns. Additionally, MC1R genetic testing has shown promise in motivating behavior change and increasing communication about skin cancer risk, which may help in early detection and prevention of melanoma. ^{1 2 3 4 5}

Is the educational intervention for skin cancer prevention safe for humans?

The educational interventions for skin cancer prevention, such as sun protection counseling and melanoma risk education, have been developed and tested in various studies without any reported safety concerns, indicating they are generally safe for humans. ^{5 6 7 8 9}

How does the Skin Cancer Prevention Strategies treatment differ from other skin cancer prevention methods?

This treatment is unique because it combines personalized education, genetic testing for MC1R (a gene linked to melanoma risk), and UV photography to create a tailored action plan for sun protection, unlike traditional methods that often focus solely on general education or sunscreen use. ^{1 2 10 11 12}

Research Team

Yelena Wu, PhD

Principal Investigator

University of Utah

Jennifer Hay, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for undergraduate students over 18 who have tanned indoors once in the past year, experienced at least one sunburn last year, and use sunscreen or other sun protection infrequently. They must also engage in outdoor tanning to some degree. Those with a history of skin cancer or who don't read/speak English cannot participate.

Inclusion Criteria

You have used indoor tanning at least once in the past year.

I had at least one sunburn in the past year.

Enrolled as an undergraduate student

Exclusion Criteria

I have had skin cancer before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment on sunburn occurrence, sun protection behaviors, and tanning behaviors

1 week

1 visit (virtual)

Intervention

Participants receive the optimized intervention including education on skin cancer and prevention strategies, and may receive UV Photo, Action Plan, and/or MC1R Testing

1 month

1 visit (in-person)

Post-Intervention Assessment

Participants complete assessments at 1-month, 4-months, and 15-months post-intervention to evaluate sunburn occurrence and sun protection behaviors

15 months

3 visits (virtual)

Follow-up

Participants are monitored for changes in sunburn occurrence, sun protection behaviors, and tanning behaviors

15 months

Treatment Details

Interventions

• Action Plan
• Education
• MC1R Test
• UV Photo

Trial Overview The study tests whether UV photos, an action plan for sun protection, and MC1R genetic testing can prevent sunburns among undergraduates. Participants will be assessed four times over 15 months to see which methods work best alone or combined.

Participant Groups

Group I: Education + UV Photo + MC1R Test Experimental Treatment 3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group II: Education + UV Photo Experimental Treatment 2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.

Group III: Education + MC1R Test Experimental Treatment 2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group IV: Education + Action Plan + UV Photo + MC1R Test Experimental Treatment 4 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group V: Education + Action Plan + UV Photo Experimental Treatment 3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and receive a printout of a photo of their face in visible light and UV light from the VISIA Complexion Analysis system.

Group VI: Education + Action Plan + MC1R Test Experimental Treatment 3 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies, complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure, and provide a saliva sample using an Oragene® clinical-grade saliva kit and receive individualized results following MC1R sequencing.

Group VII: Education + Action Plan Experimental Treatment 2 Interventions

Students in this intervention will receive education on skin cancer and prevention strategies and complete an individualized sun protection and tanning worksheet for situations in which they receive UVR exposure.

Group VIII: Education Experimental Treatment 1 Intervention

Students in this intervention will receive education on skin cancer and prevention strategies.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A study involving 1,573 high school students tested four different interventions to improve skin cancer prevention behaviors, all of which significantly increased sun protection practices.

The intervention using a personalized UV damage photograph was most effective in reducing intentional tanning and sunburn, while a behavior change worksheet was better at increasing overall sun protection use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A four-group experiment to improve Western high school students' sun protection behaviors. Wu, YP., Parsons, BG., Nagelhout, E., et al.[2020]

Inherited variations in the MC1R gene are a strong indicator of increased melanoma risk, even in individuals who may not show typical signs of sun sensitivity.

Research into MC1R genetic risk screening could lead to better prevention and early detection of melanoma, potentially improving outcomes through early surgical intervention or reducing the overall incidence of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marshaling the Translational Potential of MC1R for Precision Risk Assessment of Melanoma. Kanetsky, PA., Hay, JL.[2023]

A study involving 50 patients with a history of nonmelanoma skin cancer showed high interest in genetic testing for melanoma risk, with 92% of those who logged onto the study website opting for testing and 95% returning their saliva samples.

After receiving risk feedback from MC1R testing, most participants reported low distress levels and significant communication about skin cancer risk with family (92%) and physicians (80%) by three months, indicating that genetic testing can facilitate important health discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest and Utility of MC1R Testing for Melanoma Risk in Dermatology Patients with a History of Nonmelanoma Skin Cancer. Hay, JL., Lee, EH., Christian, SN., et al.[2022]

A study involving 39 melanoma survivors showed that 84.6% found UVR sensors useful for understanding sun exposure conditions and receiving real-time alerts, indicating a strong interest in using technology to enhance sun protection.

Participants expressed a desire for UVR sensors to be small and integrated with other devices, but also raised concerns about the interpretability and convenience of wearing such sensors in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward a precision behavioral medicine approach to addressing high-risk sun exposure: a qualitative analysis. Stump, TK., Spring, B., Marchese, SH., et al.[2022]

A new patient counseling approach for sun protection was developed specifically for outdoor workers diagnosed with skin conditions related to UV exposure, based on qualitative interviews and expert reviews.

The counseling program includes customizable modules that address individual patient needs, emphasizing interactive and educational components to improve sun protection behaviors among outdoor workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention of UV-induced skin cancer: development and pilot testing of an educational patient counseling approach for individual sun protection as standard procedure of patient care. Ludewig, M., Rocholl, M., John, SM., et al.[2022]

In a 3-month trial involving 1000 at-risk women, those who received online education on skin self-examination (SSE) showed a significantly higher initiation rate of SSE (96.2%) compared to the control group (48.1%), indicating the effectiveness of educational interventions in promoting self-monitoring for melanoma.

Women in the SSE group not only increased their confidence in performing skin checks but also identified more atypical nevi (38.5% vs. 8.4%) and melanomas (25.6% vs. 4.7%) during healthcare visits, suggesting that SSE education can enhance early detection of skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanoma detection by skin self-examination targeting at-risk women: A randomized controlled trial with telemedicine support for concerning moles. Robinson, JK., Wahood, S., Ly, S., et al.[2023]

The educational intervention was well-received by both parents and children, leading to a significant increase in knowledge about melanoma risk and preventive behaviors among participants.

After the intervention, children reported a higher perceived risk of melanoma and showed increased engagement in sun protective behaviors, indicating the intervention's effectiveness in promoting preventive actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel educational intervention targeting melanoma risk and prevention knowledge among children with a familial risk for melanoma. Wu, YP., Nagelhout, E., Aspinwall, LG., et al.[2019]

Education during well-child examinations is crucial for melanoma prevention, as it allows healthcare providers to inform patients and parents about risk factors and preventive measures.

The primary modifiable risk factor for melanoma is sun exposure, and patients should be advised on sun avoidance, protective clothing, and proper sunscreen application to reduce their risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nevi in children: a practical approach to evaluation. Prok, LD., Arbuckle, HA.[2019]

A new educational intervention has been developed for children aged 8-17 with a family history of melanoma, focusing on understanding their risk and preventive behaviors like sun protection.

The intervention combines insights from various fields, including dermatology and health education, to effectively communicate the importance of preventing DNA damage and reducing melanoma risk in at-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Educational Program Integrating Concepts of Genetic Risk and Preventive Strategies for Children with a Family History of Melanoma. Wu, YP., Aspinwall, LG., Nagelhout, E., et al.[2019]

The Task Force on Community Preventive Services recommends two effective interventions to reduce unprotected UV exposure and skin cancer risk: educational and policy approaches in primary schools and recreational sites that promote sun protective behaviors like wearing protective clothing.

There is insufficient evidence for the effectiveness of various other interventions, highlighting the need for further research in areas such as child care centers, secondary schools, and community-wide campaigns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing skin cancer: findings of the Task Force on Community Preventive Services On reducing Exposure to Ultraviolet Light. Saraiya, M., Glanz, K., Briss, P., et al.[2016]

Skin cancer is highly preventable, especially in sun-sensitive populations, and effective primary prevention campaigns are crucial for raising awareness about sun protection measures.

Current prevention initiatives have had limited success in changing behaviors or reducing skin cancer mortality, particularly among elderly men, who are the most affected demographic for melanoma mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population education in preventing skin cancer: from childhood to adulthood. de Haas, ER., Nijsten, T., de Vries, E.[2010]

References

1. England pubmed.ncbi.nlm.nih.gov

A four-group experiment to improve Western high school students' sun protection behaviors. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Marshaling the Translational Potential of MC1R for Precision Risk Assessment of Melanoma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Interest and Utility of MC1R Testing for Melanoma Risk in Dermatology Patients with a History of Nonmelanoma Skin Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Toward a precision behavioral medicine approach to addressing high-risk sun exposure: a qualitative analysis. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Secondary prevention of UV-induced skin cancer: development and pilot testing of an educational patient counseling approach for individual sun protection as standard procedure of patient care. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Melanoma detection by skin self-examination targeting at-risk women: A randomized controlled trial with telemedicine support for concerning moles. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

A novel educational intervention targeting melanoma risk and prevention knowledge among children with a familial risk for melanoma. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Nevi in children: a practical approach to evaluation. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Development of an Educational Program Integrating Concepts of Genetic Risk and Preventive Strategies for Children with a Family History of Melanoma. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

Current State of Skin Cancer Prevention: A Systematic Review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Preventing skin cancer: findings of the Task Force on Community Preventive Services On reducing Exposure to Ultraviolet Light. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Population education in preventing skin cancer: from childhood to adulthood. [2010]